MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G35359
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# pr (b)(4).Occupation: healthcare professional, but title is unknown.Pma/510(k): p140016.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: component separation.(b)(6) 2019: proximal extension of thoracic endograft with a cook zta-pt 42 x 38 covering the left subclavian artery, placement of thoracic endograft cook zta-p 38 x 167 between the connection of the previous tevar and branch graft.Placement of 3 aptus screws in the proximal thoracic stent graft.Coil embolization of left subclavian artery.Balloon angioplasty of superior mesenteric artery stent and left renal artery stent with a 10 x 2 balloon.Patient outcome: patient tolerated the procedure.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: on (b)(6) 2017, a 67-year-old female patient underwent an endovascular procedure in which a zta-p-38-167-w, lot e3510679 (complaint device, manufactured at william cook europe) and a custom made device fen-thoraco-abdominal-graft (cmd) (manufactured at william cook australia) was implanted along with additional abdominal stent-graft devices.As per information received, the zta- and cmd components separated 823 days later on (b)(6) 2019.Cook was notified of this event through an excel spreadsheet made available to cook by (b)(6) clinic.On (b)(6) 2019, a proximal extension of the thoracic endograft was performed with a cook zta-pt 42 x 38 covering the left subclavian artery, placement of thoracic endograft cook zta-p 38 x 167 between the connection of the previous tevar and branched graft, and placement of 3 aptus screws in the proximal thoracic stent graft.Coil embolization of left subclavian artery is also noted and balloon angioplasty of superior mesenteric artery stent and left renal artery stent with a 10 x 2 balloon.It is further noted that the patient tolerated the procedure.This complaint is related to wce complaints (b)(4) (manufacturer ref #3002808486-2022-00002, zta-p-38-167-w, type 1a endoleak).Five ctas (dated (b)(6) 2016, (b)(6) 2017, (b)(6) 2018, (b)(6) 2019 and (b)(6) 2019) including pre-procedure, post-procedure and follow-up imaging, and procedural angiography packages (dated (b)(6) 2016, (b)(6) 2019) were provided for the investigation.The provided imaging underwent analysis and a clinical review for the investigation.As per imaging analysis, the following measurements were noted: (b)(6) 2016: maximum thoracic aorta aneurysm diameter is 60mm, maximum localized aortic angulation of the distal thoracic aorta: 20.8.(b)(6) 2017 ¿ procedural angio: 2 stent overlap.(b)(6) 2017: length of overlap between zta and cmd is 41.6mm / 2 stents and maximum thoracic aorta aneurysm diameter is 60 mm (aortic diameter at distal end of zta: 59.9).Maximum localized aortic angulation (in area of zta) is 30.3 degrees.(b)(6) 2018: length of overlap between zta and cmd is 31.9mm / 1.5 stents and aortic diameter at distal end of zta: 60.4.Maximum localized aortic angulation (in area of zta) is 21.8.(b)(6) 2019: partial loss of overlap between the alpha graft and cmd is noted in the imaging analysis with overlap length measured to 0 / 8,2mm (bias) with number of stent(s) overlap between zta and cmd <1.Aorta diameter at distal end of zta is 60.1, maximum thoracic aorta aneurysm diameter 63,2mm, maximum localized aortic angulation (in area of zta) is 43.4.As per clinical assessment, following comments were noted: (b)(6) 2016 (pre-procedure imaging): "there is a good landing zone proximally with a diameter of 39mm just distal to the l.Subclavian artery (lsa).The taaa extends down to the distal abdominal aorta where it ends above the bifurcation with an angulation to the right".(b)(6) 2017 (post-procedure cta), an alpha thoracic graft and a cmd have been deployed along with adjunct devices: "there is a 2-stent overlap down to just above the coeliac fenestration in the cmd", and "the region of the overlap is within the aneurysm, and lies centrally within the lumen, with no contact with the aortic wall at that point.".(b)(6) 2018 (follow-up imaging): "the overlap appears to have decreased to about 1.5 stents, and there appears to be a small distal migration of the cmd.".Next follow-up imaging set: "the alpha graft and the cmd have separated, with the alpha graft pointing up and out of the cmd, towards the patient¿s right side, with a large type 3 endoleak at the separation".A type 1a endoleak (addressed in (b)(4)) related to the alpha graft is also noted on this imaging.(b)(6) 2019 (post secondary intervention): "in addition to the repair of the proximal type 1a endoleak, the graft separation between the distal alpha graft and the top of the cmd has also been repaired with another tube graft." documents reviewed provided that the cmd was planned by the customer and that the cmd was planned with no proximal fixation.Regarding potential causes for the separation, it is stated in the clinical assessment: "the main problem has been at the zone of overlap between the initial alpha thoracic graft and the top of the cmd.The main problem here would seem to be that there was no oversizing of whichever of the two devices was placed inside the other.The exact order of placement is in question.But both devices were 38mm diameter, so it was a slip fit and not an interference fit.This slip fit allowed both a small amount of distal migration of the cmd (a few mm, as evidenced by the shift and compression of the coeliac and sma stents) but mainly allowed the alpha graft to pull out of the top of the cmd.The reasons for the movement can only be speculated, but may be due to some lengthening of the thoracic aorta, increasing tortuosity, and aneurysm enlargement ¿ probably all three.Add into the mix the respiratory movement of the diaphragm, particularly with any coughing, plus the pulsation of the aorta in both the longitudinal and transverse directions, and grafts that are not fixed to each other (i.E.Slip fit vs interference fit) are likely to drift apart.This is in addition to the initial overlap of only 2 stents, when we recommend at least 3 stent overlap." imaging reviews concluded that the initial overlap length at implantation was approximately 2 stent lengths.As per instructions for use (ifu) shipped with this type of device, "the zenith alpha thoracic endovascular graft is a two-piece cylindrical endovascular graft consisting of proximal and distal components.".With regards to combining proximal and distal alpha components, the ifu notes "the minimum required amount of overlap between devices is three stents.Less than a three-stent overlap may result in endoleak (with or without component separation).".Review of cmd and alpha documentation revealed that the cmd was designed with insufficient length between proximal graft edge and the proximal-most fenestration to allow for a three stent overlap without covering the fenestration.Review of the device history record provided no evidence that the device was manufactured outside of specifications.The complaint is confirmed based on the information and imaging provided for the complaint.It was not possible to establish a single, conclusive cause for this event, however based on the reviews provided for the investigation it is assessed that the following factors potentially contributed to the event: ¿ insufficient overlap between the alpha and cmd device.¿ patient anatomy (morphology changes and large aneurysm) cook will reopen the complaint if further information is received.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information 25jan2022: procedure date (b)(6) 2017.Ct date (b)(6) 2017 number of stents overlap 2.Ct date (b)(6) 2018 number of stents overlap 1,5.Ct date (b)(6) 2019 number of stents overlap 0.Component separation date (b)(6) 2019.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12645619
• Report Number: 3002808486-2021-01881
• Device Sequence Number: 1376022
• Product Code: MIH
• UDI-Device Identifier: 10827002353593
• UDI-Public: (01)10827002353593(17)191025(10)E3510679
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2019
• Device Model Number: G35359
• Device Catalogue Number: ZTA-P-38-167-W
• Device Lot Number: E3510679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown